MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	300-01-12
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Dislocation (2374); Inadequate Osseointegration (2646)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 320-06-38 - glenosphere 38mm.(b)(6), 320-15-01 - eq rev glenoid plate.(b)(6), 320-15-05 - eq rev locking screw.(b)(6), 320-20-00 - eq reverse torque defining screw kit.(b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6), 322-10-00 - humeral adapter tray, +0.(b)(6), 322-38-00 - 145-deg pe 38mm hum liner +0.(b)(6), 531-55-88 - ergo gps 3.2mm drill kit sterile.(b)(6), 531-78-20 - shouldr gps hex pins kit.Multiple mdr reports were filed for this event, please see associated report: 1038671-2025-02161.Customer has indicated that the product is in process of being returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
As reported, approximately two weeks post the initial right reverse total shoulder arthroplasty, the patient dislocated for a second time and the surgeon decided to go up a size on the stem.The stem was also loose, but the surgeon believes this may have happened during the previous closed reduction.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.

• Brand Name: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22091074
• Report Number: 1038671-2025-02162
• Device Sequence Number: 15184923
• Product Code: PHX
• UDI-Device Identifier: 10885862283016
• UDI-Public: 10885862283016
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 300-01-12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male